Europe — EMA
Grazax
Grazax sublingual tablet (225 µg Phleum pratense) is a prescription allergy immunotherapy for seasonal grass‑pollen rhinitis and rhinoconjunctivitis in the EU.
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What is Phleum Pratense (225)?
Grazax is a sublingual tablet containing 225 µg of standardized Phleum pratense (Timothy grass) allergen extract. It is prescribed as an allergen immunotherapy for patients with seasonal allergic rhinitis or rhinoconjunctivitis caused by grass pollen. The medication is administered under the tongue and is available by prescription in the European Union.
What is Phleum Pratense (225) used for?
Grazax is indicated for the treatment of grass‑pollen allergy symptoms and to modify the underlying allergic response. It is used as a disease‑modifying therapy rather than a rescue medication.
- Seasonal allergic rhinitis caused by Timothy grass pollen. - Allergic rhinoconjunctivitis due to grass pollen exposure. - Long‑term immunotherapy to reduce the need for symptomatic antihistamines. - Prevention of symptom escalation during peak grass season. - Adjunct to environmental control measures for grass pollen allergy.
What are the side effects of Phleum Pratense (225)?
Side effects of Grazax are generally mild and related to local exposure of the oral mucosa, but rare systemic reactions can occur.
Common: - Mild oral itching or tingling. - Sore throat or mild throat irritation. - Transient mouth or tongue swelling. - Mild gastrointestinal discomfort. - Nasal congestion or runny nose. - Headache.
Serious: - Anaphylaxis or severe systemic allergic reaction. - Persistent or worsening throat swelling that interferes with breathing. - Severe urticaria (hives) beyond the oral cavity. - Angioedema involving the face or lips. - Bronchospasm or wheezing. - Cardiovascular symptoms such as hypotension.
What precautions apply to Phleum Pratense (225)?
Before starting Grazax, patients should consider several safety factors and follow medical guidance.
- Confirm diagnosis of grass‑pollen allergy with appropriate testing. - Do not use if you have a history of severe anaphylaxis to grass pollen. - Discuss any current immunotherapy, biologic agents, or recent vaccinations with your clinician. - Use caution if you have uncontrolled asthma or chronic respiratory disease. - Pregnant or breastfeeding individuals should consult a healthcare professional before use. - Keep the tablet in the original container, out of reach of children. - Discontinue use and seek medical attention if severe side effects develop.
What does Phleum Pratense (225) interact with?
Grazax may interact with other medications or substances that affect immune response or increase allergy risk.
Avoid: - Concurrent use of other allergen immunotherapy products without medical supervision. - Systemic corticosteroids taken within two weeks of initiating therapy.
Use with caution: - Beta‑blockers, which may mask symptoms of anaphylaxis. - ACE inhibitors, which can exacerbate angioedema. - Antihistamines, as they may reduce local tolerability but do not affect efficacy. - Live vaccines, which should be administered at least four weeks before starting Grazax. - Immunosuppressive agents, which could alter the immunologic response to the tablet.
Frequently asked questions
What is the active ingredient in Grazax and how is it standardized?+
How does sublingual immunotherapy with Grazax work to reduce allergy symptoms?+
Who is an appropriate candidate for Grazax therapy?+
When should Grazax be started relative to the grass pollen season?+
What is the recommended administration method for Grazax tablets?+
Can Grazax be used together with antihistamines or nasal steroids?+
What are the most common side effects experienced with Grazax?+
What signs indicate a serious reaction that requires immediate medical attention?+
Is Grazax safe for use during pregnancy or breastfeeding?+
How long does a typical course of Grazax treatment last?+
What should be done if a dose of Grazax is missed?+
Are there any special storage requirements for Grazax tablets?+
Product details
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